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LEADER ANTIFUNGAL TOLNAFTATE by REMEDYREPACK INC.

Medically reviewed on October 23, 2017

Dosage form: cream
Ingredients: TOLNAFTATE 10mg in 1g
Labeler: REMEDYREPACK INC.
NDC Code: 70518-0794

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient                                                     Purpose

Tolnaftate 1%.........................................................Antifungal

Uses

  • proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • proven effective in the prevention of athlete's foot with daily use
  • for effectively relief of itching, burning and cracking

Warnings

For external use only

When using this product avoid contact with the eyes.

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Wash affected area and dry thoroughly
  • Apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor
  • Supervise children in the use of this product
  • For athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • use daily for 4 week; if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

Other Information

  • store between 20 o to 25 oC (68 o to 77 oF)
  • Lot No. & Exp. Date: see box or see crimp of tube

Inactive Ingredients

butylated hydroxytoluene, cetanol, liquid paraffin, methylparaben, prolyoxyethylene cetyl ether, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Made in Korea

DRUG: LEADER ANTIFUNGAL TOLNAFTATE

GENERIC: TOLNAFTATE

DOSAGE: CREAM

ADMINSTRATION: TOPICAL

NDC: 70518-0794-0

PACKAGING: 28 g in 1 TUBE

ACTIVE INGREDIENT(S):

  • TOLNAFTATE 10mg in 1g

INACTIVE INGREDIENT(S):

  • BUTYLATED HYDROXYTOLUENE
  • WATER
  • PROPYLPARABEN
  • SORBITAN MONOSTEARATE
  • PROPYLENE GLYCOL
  • CETYL ALCOHOL
  • METHYLPARABEN
  • PARAFFIN
  • STEARYL ALCOHOL

LEADER ANTIFUNGAL TOLNAFTATE 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0794(NDC:37205-197)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
CETYL ALCOHOL 
PARAFFIN 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SORBITAN MONOSTEARATE 
STEARYL ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:70518-0794-028 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/18/2017
Labeler - REMEDYREPACK INC. (829572556)

 
REMEDYREPACK INC.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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